GMP Cleaner
Durham, NC 27712
12 months
Shift Schedule: Initially - Monday - Friday (7:00am-3:30pm), however, our New Hire Orientation will be for one week (M-F; 8am-4:30pm). Steady State Production schedule will start at the end of 3Q/4Q and will be for 3rd Shift; Sunday - Thursday (10:00pm-6:30am).

SAM test required

Summary
Manufacturing Operations teams are the people that make therapies for our patients. We work in the manufacturing plants with a "Safety First, Quality Always" mindset, striving for continuous improvement, and earn our right to produce. We work in local plants connected to our global manufacturing network supplying the highest quality of raw materials, intermediates, and finished products.

This role is within a capital project start-up in Durham, North Carolina. The new facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork.

Responsibilities may include but are not limited to:
* Supports project team as a CUCO (Clean Up Change Over) SME through start-up, commissioning, qualification through licensure and ramp up of facility.
* Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while coordinating with appropriate personnel.
* Actively supports production areas by performing CUCO for Production Support & Media, Drug Substance, and Drug Product. Activities are as followed but not limited to: General Housekeeping/Facility & Equipment Cleaning; Performing Bowie Dick Tests/Leak for Autoclaves; Running Washers & Autoclaves; Cleaning Closed Restricted Access Barriers (cRABS); Performing cRAB pre-checks (Seal Tests/Leak Tests/Glove Integrity Tests); Fill Line Support; Material Management/Inventory Checks (Kitting and Staging Items); Gowning Restocking; Filter Integrity Testing; Waste Management.

Education Minimum Requirement:
* High School Diploma/GED or higher

Required Experience and Skills:
* Demonstrated written and verbal communications skills
* Must be able to successfully pass and maintain aseptic gowning qualifications. Aseptic gowning requires that all skin and hair be covered through wearing the following: beard/mustache cover, hair net, hood and facemask, goggles, jumpsuit, gloves, and boots.
* Computer literacy (internet browsers, e-mail, spreadsheets, word processing)
* Must be willing and able to lift 50 lbs, bend, stoop, squat, crawl, twist, climb ladders, and wear a respirator
* This position will initially be 1st Shift, Monday - Friday (7am - 3:30pm). Will transition to 3rd Shift, Sunday - Thursday (10pm - 6:30am) 3Q/4Q 2024.
* Successful completion of TB titer and Chest X-ray are required.

Preferred Experience and Skills (General):
* BioWork Certificate (working in an FDA or similar regulated industry)
* Experience with automated systems (MES, SAP)
* Experience with on-the-floor cGMP manufacturing and familiarity with regulatory requirements and Good Documentation Practices (GDP)
* Demonstrated ability to work both independently and as a part of a team
* Experience with CUCO (Clean Up Change Over) Activities
* Material Management
* Autoclave & Washer Experience (Bowie Dick Test; Glove Integrity Testing)